MAUDE Adverse Event Report: CUTERA, INC. LIMELIGHT; PULSED LIGHT HANDPIECE

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	12/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On 12 june 2024, cutera received photographic evidence of a partial thickness dermal burn located on the patient's right lower arm.This injury is reported to have occurred subsequent to a limelight procedure that was performed in (b)(6) 2023.The clinic has multiple limelight handpieces in its inventory and is currently unable to provide the serial number of the handpiece utilized during the procedure.The clinic reported that the limelight handpiece was returned to cutera; however, there is no record of a limelight handpiece being returned to cutera from this account after december 2023.At this time, cutera is awaiting further details pertaining to the patient, the exact nature of the treatment performed, and the resolution of the burn injury.This information is pending as cutera is in the process of obtaining these details from the clinic.
Event or Problem Description
This is a follow-up to the initial emdr filed on july 2, 2024.As reported initially, cutera received photographic evidence of a partial thickness dermal burn located on the patient's right lower arm on (b)(6) 2024.This injury is reported to have occurred subsequent to a limelight procedure that was performed in (b)(6) 2023.The clinic has multiple limelight handpieces in its inventory and was unable to provide the serial number of the handpiece utilized during the procedure.The clinic reported that the limelight handpiece was returned to cutera; however, there is no record of a limelight handpiece being returned to cutera from this account after (b)(6) 2023.At the time of the initial emdr, cutera was awaiting further details pertaining to the patient, the exact nature of the treatment performed, and the resolution of the burn injury.However, despite multiple follow-up attempts, the clinic has not provided any additional details.

• Brand Name: LIMELIGHT
• Common Device Name: PULSED LIGHT HANDPIECE
• Manufacturer (Section D): CUTERA, INC.; 3240 bayshore blvd; brisbane CA 94005
• Manufacturer (Section G): CUTERA, INC.; 3240 bayshore blvd; brisbane CA 94005
• Manufacturer Contact: julia brown ; 3240 bayshore blvd.; brisbane, CA 94005 ; 4156575575
• MDR Report Key: 19660718
• Report Number: 2954354-2024-00010
• Device Sequence Number: 17848217
• Product Code: ILY
• UDI-Device Identifier: 00816722022110
• UDI-Public: 00816722022110
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White